CPVT1Phase 2CPVTNCT06005428
Effectiveness of CRD-4730 in Participants With Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
A Phase 2 study testing CRD-4730 in people with CPVT1 and Heart Defects, Congenital, run by Cardurion Pharmaceuticals, Inc. at 11 sites in 4 countries.
Trial summary
This is a Phase 2, multicenter, double-blind, sponsor unblinded, placebo-controlled, single-dose clinical study of CRD-4730 to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CRD-4730 when administered as single oral doses to participants with Catecholaminergic Polymorphic… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- CPVT1, Heart Defects, Congenital, Heart Diseases
- What is being tested?
- CRD-4730
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 7 Nov 2023to 31 May 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or Females ≥18 years of age, at screening.
- Confirmed CPVT diagnosis, based on genetic screening for a known RyR2 mutation and a clinical phenotype consistent with CPVT at screening.
- The participant can perform an EST during which frequent premature ventricular contraction (PVCs) (≥10 per minute), ventricular bigeminy, or higher-grade VA (equivalent to a VA score ≥2) are identified by the investigator.
- Stable doses of any anti-arrhythmic medication, except amiodarone, for 4 weeks prior to screening.
- Adhere to all contraceptive criteria.
Who cannot join
- Clinically significant structural heart disease, diagnosis of heart failure, or clinically significant coronary artery disease.
- History of a myocardial infarction, cerebrovascular accident, or transient ischemic attack within 3 months of screening.
- History of malignancy within the past 5 years at screening (except successfully treated basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin or cervical carcinoma in situ).
- Female participant that is pregnant or lactating/ breastfeeding, or has plans to do so during the study or within 3 months following last dose of study drug.
- Use of amiodarone with 3 months prior to screening. NOTE: other protocol defined Inclusion/ Exclusion criteria may apply.
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
Canada4 sites
Stollery Children's Hospital University of Alberta
Edmonton, Alberta, T6G 2R7
University of Western Ontario
London, Ontario, N6A 5A5
University of British Columbia (UBC) Hospital
Vancouver, British Columbia, V5Z 1M9
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3N1
United States3 sites
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Cleveland Clinic Children's Hospital
Cleveland, Ohio, 44195
Baylor College of Medicine
Houston, Texas, 77030
France3 sites
Hôpital Louis Pradel
Bron, 69677
Hôptal Nord Laennec
Nantes, Loire-Atlantique, 44805
Groupe Hospitalier Bichat Claude Bernard
Paris, 75018
Italy1 site
IRCCS Pavia Istituti Clinici Scientifici Maugeri Spa Società Benefit
Pavia, Lombardy, 27100
About this study
Official title: A Phase 2A, Investigator & Subject Blinded, Sponsor Unblinded, Placebo-Controlled, Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of CRD-4730 in Participants With Catecholaminergic Polymorphic Ventricular Tachycardia
This is a Phase 2, multicenter, double-blind, sponsor unblinded, placebo-controlled, single-dose clinical study of CRD-4730 to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CRD-4730 when administered as single oral doses to participants with Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT). The study will have 2 cohorts in which participants with CPVT will participate in a 3-period, randomized 2-sequence study. Each participant will receive 2 different doses of CRD-4730 and 1 dose of matching placebo, with each study drug administered as a single dose.
- Being tested
- CRD-4730, Placebo
- Keywords
- CaMKII, Catecholaminergic polymorphic VT, Ventricular Tachycardia, CRD-4730
- Medical subject headings
- Heart Defects, Congenital, Heart Diseases, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRD-4730Drug
Oral CRD-4730 in capsule form
PlaceboDrug
Placebo to match CRD-4730 in capsule form
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 | Experimental | CRD-4730 Dose 1 capsule Receives: Drug: CRD-4730 |
| Dose 2 | Experimental | CRD-4730 Dose 2 capsule Receives: Drug: CRD-4730 |
| Dose 3 | Placebo comparator | Placebo capsule to match CRD-4730 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Emergent Adverse Events (TEAEs)
The number of participants with TEAEs including drug-related AEs, serious AEs (SAEs), and AEs leading to study drug discontinuation will be assessed.
Measured: Baseline to Day 22
Changes in Laboratory Assessments
The number of participants who have normal/ abnormal values at Baseline compared to normal/ abnormal values post-Baseline will be assessed for hematology, serum chemistry and urinalysis.
Measured: Baseline to Day 15
Changes in Vital Signs Measurement: Systolic and Diastolic blood pressure
Percent change from Baseline to post Baseline will be assessed for systolic and diastolic blood pressure
Measured: Baseline to Day 15
Changes in Vital Signs Measurement: Pulse Rate
Percent change from Baseline to post Baseline will be assessed for pulse rate
Measured: Baseline to Day 15
Changes in Vital Signs Measurement: Respiratory Rate
Percent change from Baseline to post Baseline will be assessed for respiratory rate
Measured: Baseline to Day 15
Changes in Vital Signs Measurement: Body Temperature
Percent change from Baseline to post Baseline will be assessed for body temperature
Measured: Baseline to Day 15
Changes in Physical Exam
General physical exams will be carried out to detect any abnormalities in the cardiovascular, respiratory and other body systems
Measured: Baseline to Day 22
Changes in Electrocardiogram (ECG) Measurements
Number of participants who have normal/abnormal ECG measurements at Baseline will be compared to normal/abnormal ECG measurement post Baseline
Measured: Baseline to Day 22
Secondary outcomes (4)
Change in Ventricular Arrhythmia (VA) score during Exercise Stress Test (EST)
The VA score is a physician administered score on a scale of 0-5 with higher numbers being worse.
Measured: Baseline to Day 1
Change in Ventricular Arrhythmia (VA) score during Exercise Stress Test (EST)
The VA score is a physician administered score on a scale of 0-5 with higher numbers being worse.
Measured: Baseline to Day 8
Change in Ventricular Arrhythmia (VA) score during Exercise Stress Test (EST)
The VA score is a physician administered score on a scale of 0-5 with higher numbers being worse.
Measured: Baseline to Day 15
Assessment of PK effect
Plasma concentrations of CRD-4730 over time for each treatment period
Measured: Baseline through Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start7 Nov 2023
- Primary completion31 May 2025
- Study completion31 May 2025
Why it stopped: The early termination of the clinical trial is due to an internal administrative and business decision, the study is not being terminated for safety reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CPVT1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 3-period randomized 2-sequence study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardurion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Homsy, M.D., Ph.D., Study director, Executive Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005428
- Sponsor's protocol ID
- CRD-4730-201
- Acronym
- CPVT
- Status last verified
- May 2026
- First submitted
- 8 Aug 2023
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2A, Investigator & Subject Blinded, Sponsor Unblinded, Placebo-Controlled, Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of CRD-4730 in Participants With Catecholaminergic Polymorphic Ventricular Tachycardia
- ClinicalTrials.gov ID
- NCT06005428
- Acronym / sponsor ID
- CPVT / CRD-4730-201
- Keywords
- CaMKII, Catecholaminergic polymorphic VT, Ventricular Tachycardia, CRD-4730
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The early termination of the clinical trial is due to an internal administrative and business decision, the study is not being terminated for safety reasons.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Cardurion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2, multicenter, double-blind, sponsor unblinded, placebo-controlled, single-dose clinical study of CRD-4730 to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CRD-4730 when administered as single oral doses to participants with Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT). The study will have 2 cohorts in which participants with CPVT will participate in a 3-period, randomized 2-sequence study. Each participant will receive 2 different doses of CRD-4730 and 1 dose of matching placebo, with each study drug administered as a single dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 3-period randomized 2-sequence study
| Arm | Type | Receives |
|---|---|---|
| Dose 1 | Experimental | Drug: CRD-4730CRD-4730 Dose 1 capsule |
| Dose 2 | Experimental | Drug: CRD-4730CRD-4730 Dose 2 capsule |
| Dose 3 | Placebo comparator | Drug: PlaceboPlacebo capsule to match CRD-4730 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or Females ≥18 years of age, at screening.
- Confirmed CPVT diagnosis, based on genetic screening for a known RyR2 mutation and a clinical phenotype consistent with CPVT at screening.
- The participant can perform an EST during which frequent premature ventricular contraction (PVCs) (≥10 per minute), ventricular bigeminy, or higher-grade VA (equivalent to a VA score ≥2) are identified by the investigator.
- Stable doses of any anti-arrhythmic medication, except amiodarone, for 4 weeks prior to screening.
- Adhere to all contraceptive criteria.
Key exclusion criteria (5 listed)
- Clinically significant structural heart disease, diagnosis of heart failure, or clinically significant coronary artery disease.
- History of a myocardial infarction, cerebrovascular accident, or transient ischemic attack within 3 months of screening.
- History of malignancy within the past 5 years at screening (except successfully treated basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin or cervical carcinoma in situ).
- Female participant that is pregnant or lactating/ breastfeeding, or has plans to do so during the study or within 3 months following last dose of study drug.
- Use of amiodarone with 3 months prior to screening. NOTE: other protocol defined Inclusion/ Exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRD-4730Oral CRD-4730 in capsule form | Drug | Dose 1, Dose 2 |
| PlaceboPlacebo to match CRD-4730 in capsule form | Drug | Dose 3 |
Primary outcome
Treatment Emergent Adverse Events (TEAEs)
Time frame: Baseline to Day 22
The number of participants with TEAEs including drug-related AEs, serious AEs (SAEs), and AEs leading to study drug discontinuation will be assessed.
Changes in Laboratory Assessments
Time frame: Baseline to Day 15
The number of participants who have normal/ abnormal values at Baseline compared to normal/ abnormal values post-Baseline will be assessed for hematology, serum chemistry and urinalysis.
Changes in Vital Signs Measurement: Systolic and Diastolic blood pressure
Time frame: Baseline to Day 15
Percent change from Baseline to post Baseline will be assessed for systolic and diastolic blood pressure
Changes in Vital Signs Measurement: Pulse Rate
Time frame: Baseline to Day 15
Percent change from Baseline to post Baseline will be assessed for pulse rate
Changes in Vital Signs Measurement: Respiratory Rate
Time frame: Baseline to Day 15
Percent change from Baseline to post Baseline will be assessed for respiratory rate
Changes in Vital Signs Measurement: Body Temperature
Time frame: Baseline to Day 15
Percent change from Baseline to post Baseline will be assessed for body temperature
Changes in Physical Exam
Time frame: Baseline to Day 22
General physical exams will be carried out to detect any abnormalities in the cardiovascular, respiratory and other body systems
Changes in Electrocardiogram (ECG) Measurements
Time frame: Baseline to Day 22
Number of participants who have normal/abnormal ECG measurements at Baseline will be compared to normal/abnormal ECG measurement post Baseline
4 secondary outcomes
Change in Ventricular Arrhythmia (VA) score during Exercise Stress Test (EST)
Time frame: Baseline to Day 1
Change in Ventricular Arrhythmia (VA) score during Exercise Stress Test (EST)
Time frame: Baseline to Day 8
Change in Ventricular Arrhythmia (VA) score during Exercise Stress Test (EST)
Time frame: Baseline to Day 15
Assessment of PK effect
Time frame: Baseline through Day 15
Results and safety
The study was stopped early (reason given: The early termination of the clinical trial is due to an internal administrative and business decision, the study is not being terminated for safety reasons.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Homsy, M.D., Ph.D. study director
Executive Medical Director
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CRD-4730 in people with CPVT1 and Heart Defects, Congenital, run by Cardurion Pharmaceuticals, Inc. at 11 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Canada, United States, France, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The early termination of the clinical trial is due to an internal administrative and business decision, the study is not being terminated for safety reasons.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Emergent Adverse Events (TEAEs) (time frame: Baseline to Day 22). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.